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A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810433
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : February 7, 2014
Information provided by (Responsible Party):
Mazor Robotics

Brief Summary:
The purpose of this study is to collect data regarding the safety and feasibility of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques as described in the literature.

Condition or disease Intervention/treatment Phase
Lower Back Pain Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Safety and Feasibility Study of the GO-LIF® Approach
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: Arm 1 Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion

All patients will undergo single-level instrumented interbody spinal fusion surgery with instrumentation.

Upon induction of general anesthesia, the patient will be positioned prone on a radiolucent operating table and prepared according to standard hospital procedure. An interbody fusion will be performed according to standard procedure and as indicated by the surgeon. The interbody fusion portion of the surgery will be carried out using any current technique - such as PLIF, TLIF, PLF, PLLF, XLIF or ALIF. The fusion strategy can be performed in an open or minimally invasive manner, as indicated. The interbody device will be inserted after the screws trajectory will be drilled and a 4.5mm Trajectory holder is in place. This will assure the surgeon that no collision will occur between the interbody and the screws.

Upon completion of the fusion stage of the surgery, SpineAssist will be used to introduce the GO-LIF screws for fixation of the spinal levels to be fused.

Other Names:
  • Mazor
  • SpineAssist
  • GO-LIF

Primary Outcome Measures :
  1. The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury. [ Time Frame: prior to discharge from hospital ]
  2. Number of significant cortical breaches (>4mm), as evidenced by visual examination of a post-operative CT scan. [ Time Frame: Preferably prior to discharge from hospital, and no later than 1 month post-op ]
  3. The number of procedures that were not completed, and the reasons and causality for non-completions. [ Time Frame: Immediately post-op. ]

Secondary Outcome Measures :
  1. Plain AP, Lateral and flexion-extension radiographs. The radiographs will be examined for: • Evidence of bridging trabecular bone between the involved motion segments • Translational motion <3mm; and •Angular motion <5 degrees. [ Time Frame: 3, 6 and 12 months post-op. ]
  2. Healthcare Outcomes: the visual analogue pain scale (VAS), the Oswestry disability index (ODI) and Swiss Spinal Stenosis (SSS) Questionnaire. [ Time Frame: pre-op; 3, 6 and 12 months post-op ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Men and women, 18-80 years of age.
  2. The capability to comprehend the nature and rationale of the study and to consent to participating in the study.
  3. Unequivocal medical indication for the fixation surgery of a single motion segment of the lumbar spine.
  4. Correct coronal profile of the lumbar spine. An asymmetric collapse of the disk space in the coronal plane between the vertebral bodies envisioned for instrumentation is by itself not an exclusion criterion.

Or any of criteria below:

  1. Patients with Grade II or Grade III spondylolisthesis in the sagittal plane with preserved or normal sagittal alignment requiring single-level instrumented interbody fusion from L1 to S1. (Not excluding patient with a need to decompression)
  2. Patients must have normal alignment of the spine in the coronal view. 2. The interbody fusion approach may be TLIF or PLIF or ALIF or other, as clinically indicated.

    3. The procedure may be combined with a Micro-decompression and/or Micro-discectomy and/or direct or indirect decompression and/or laminectomy or laminotomy and/or other procedures, as clinically indicated - as long as such procedures do not compromise the structural integrity of the pedicles of the inferior vertebra or the vertebral body of either vertebra of the levels involved..

    4. Patient is 18 years or more 5. Patient is willing and able to comply with study requirements

    Exclusion Criteria:

    1. Lumbar hyperlordosis > 70° between the end plate of the lumbar vertebral body 1 and the end plate of the sacral vertebral body 1.
    2. Deformities of the vertebral bodies envisioned for instrumentation or the sacrum.
    3. Spondylolisthesis > grade 2 acc. to Meyerding.
    4. Scoliosis and other deformities in the coronal plane.
    5. Fractures of the vertebrae envisioned for instrumentation.
    6. Osteoporosis or osteopenia (see below for examination criteria).
    7. Therapy with systemic corticosteroids or immunosuppressants.
    8. Bone metabolism diseases, such as osteomalacia or Paget's disease.
    9. Post inflammatory instability of the vertebral spine.
    10. State after radiation therapy of the relevant vertebral spine region.
    11. Current Marcoumar or heparin therapy for more than 6 months at the time of operation.
    12. Malignant diseases with or without bone metastases.
    13. Immunologic-inflammatory diseases (e.g., rheumatoid arthritis).
    14. Diabetes mellitus.
    15. Infectious diseases.
    16. BMI > 30.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810433

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Dep. Of Neurosurgery , Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
Berlin, Germany, 12200
Dep. Of Orthopedic Helios Rosmann Klinik
Breisach, Germany, 79206
Dept. of Neurosurgery, Neurochirurgische Klinik Göttingen
Göttingen, Germany, 37075
Dept. of Neurosurgery, Klinikum Nordstadt Hannover
Hannover, Germany, 30167
Dep. Of Neurosurgery Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Krankenhaus Munchen Schwabing
Munich, Germany, 80804
Dep. Of Orthopedic Klinikum Grosshadern- LMU
Munich, Germany, 81377
Dep. Of Neurosurgery Paracelsus kliniken
Munich, Germany, 81927
Dept. of Orthopedics, Carmel Medical Center
Haifa, Israel, 34362
Dept. of Orthopedics Hadassah Medical Center - The Hebrew University
Jerusalem, Israel, 91120
Sponsors and Collaborators
Mazor Robotics
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Study Director: Isador H Lieberman, MD, MBA, FRCSC Texas Back Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mazor Robotics Identifier: NCT00810433    
Obsolete Identifiers: NCT00786955
Other Study ID Numbers: CLN-102
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Neurologic Manifestations
Signs and Symptoms